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WARNING LETTER

Fibromyalgia Treatment Group - FTG, LLC MARCS-CMS 614183 —

Delivery Method:
Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
James L. Sparling
Recipient Title
Manager
Fibromyalgia Treatment Group - FTG, LLC

1236 Lone Creek Drive
Eagle, ID 83616
United States

Issuing Office:
Division of Human and Animal Food Operations West VI

United States

August 26, 2021

In reply, refer to CMS 614183

WARNING LETTER

Dear Mr. Sparling:

This is to advise you that the Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.fibromyalgiatreatmentgroup.com/landers/1/, www.fibrolief.com, www.neuropathytreatmentgroup.com and www.nerverenew.com in August 2021 and has determined that you take orders there for the products Fibrolief Support Formula, Nerve Renew, Neuro Boost Optimizer, and Immune Support. We have also reviewed your social media website at www.facebook.com/fibrolief, which directs customers to https://fibrolief.com/, to purchase your products. The claims on your websites establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

Fibrolief Support Formula

Statements referring to Fibrolief Support Formula on www.fibrolief.com:

  • The product name, “Fibrolief Support Formula” (implies the product is intended for use in the mitigation and/or treatment of fibromyalgia)
  • “Reduce Debilitating Body Aches, Stiffness, Fatigue & More”
  • “Reduce chronic joint or muscle aches and stiffness”

Statements referring to Fibrolief Support Formula ingredients on www.fibrolief.com:

  • Turmeric (275mg): “…powerful anti-inflammatory and soothing properties to quickly reduce discomfort and swelling…safe alternative for acute pain relief comparable to acetaminophen.”
  • Boswellia Serrata (100mg): “Used for centuries to reduce joint and muscle discomfort, inflammation…and more.”
  • White Willow (90mg): “This extract is a natural alternative to aspirin that is safer and less irritating to the stomach lining.”
  • Celery Seed Extract (40mg): “Known to help reduce muscle spasms and alleviate painful gas and bloating. Researchers have found the compounds in celery have antioxidant characteristics and provide various healing benefits.”
  • SAM-e (65mg): “The University of Maryland Medical Center states, ‘SAMe can be effective in reducing…depressed mood.’”

Your www.fibrolief.com website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

  • “…I have had fibromyalgia for 15 years...A few months ago I learned about Fibrolief and decided to give it a try…The pain and fatigue have decreased perhaps by 70%. . ..”
  • “Fibrolief is the only thing that has helped with my fibromyalgia pain. I have been taking Fibrolief for years and it has given me my life back. I’m not totally free of pain, but it has decreased my pain by at least 80% with no side effects like with prescription drugs.”

Statements referring to Fibrolief Support Formula on www.fibromyalgiatreatmentgroup.com/landers/1/:

  • “I am going to show you how these ingredients have been shown to improve fibromyalgia symptoms and help you return to a normal life.”
  • “Reduction of lower back pain, headaches, joint and muscle pain…”

Statements referring to Fibrolief Support Formula ingredients on www.fibromyalgia treatmentgroup.com/landers/1/:

  • “What Enables The Ingredients In Fibrolief To Be So Effective At Relieving The Pain And Symptoms?”
  • “Fibrolief contains a combination of ingredients that…have helped many people achieve: Reduction of lower back pain, headaches, joint and muscle pain…”

Turmeric/Curcumin

  • “Curcumin is a potent anti-oxidant with insanely powerful anti-inflammatory and pain relieving properties. This marvel of nature has virtually no side-effects and offers vast benefits to fibromyalgia sufferers. . ..”

Boswellia AKBA (ApresFlex(C))

  • “Boswellia is a popular herb used for its benefits in fighting inflammation. Its anti-inflammatory effects involve many processes that the body uses to help heal itself, and could correlate to benefiting many chronic illnesses, such as arthritis and fibromyalgia.”

“Boswellia Serrata extract providing Acetyl-11-keto-β-boswellic acid (AKBA) has been shown to increase joint mobility and ease stiff joints.”

White Willow Bark Extract

  • “White Willow Bark extract contains the active ingredient salicin which is a Cox-1 and Cox-2 inhibitor, and acts as an anti-inflammatory and also reduces pain by inhibiting prostaglandins. Animal experimentation at Cairo University compared willow bark extract to ASA (aspirin), and found that willow bark was equally or more effective as aspirin [sic] at reducing inflammation; even though the salicin content was lower than an equivalent dose of ASA. It is recommended to take white willow bark instead of aspirin because it is less irritating to the stomach lining.”

Celery Seed Extract

  • “Celery seed extract has been used as a pain reliever for arthritis, fibromyalgia and gout. It is known to help reduce muscle spasms and to alleviate painful gas and bloating. It is also known to aid in improving the painful symptoms of fibromyalgia sufferers by reducing inflammation.”

“Celery seed contains a number of biologically beneficial substance [sic], including flavonoids high in antioxidants, coumarin with anti-coagulating effects, volatile oils ,omega-6 fatty acid linoleic acid, and the powerful healing compound 3-n-butylphthlaide (3-n-B). 3-n-B is extremely effective at reducing the action of the COX-1, COX-2, and 5-LOX pain triggers. In one study of patients with longterm joint discomfort, celery seed helped reduce tenderness and improve flexibility in a remarkable 68% of patients.”

Rhodiola Rosea

  • “[R]hodiola is typically used for fatigue, depression, sleep problems, poor attention span and poor memory.”

Bacopa Monnieri

  • “In a 2008 study of older adults, researchers found that 12 weeks of supplementation with bacopa led to significant improvements in memory, depression, anxiety, and heart rate. In a 2001 study of healthy adults, participants showed significant improvements in…memory, learning and anxiety.”

SAM-e
“Studies have shown its [sic] effective for arthritis pain and shows both analgesic and anti-inflammatory properties.”

“Europe has had SAM-e available by prescription for many years as an antidepressant, and it has been available over-the-counter in the US since 1996. Dr. Ascanio Polimeni, a renowned physician in Rome, Italy, stated that ‘... doctors in Europe prescribe SAM-e for the therapy of many conditions, including depression, chronic fatigue syndrome, and fibromyalgia.’”

“The University of Maryland Medical Center states, ‘SAMe can be effective in reducing symptoms of fibromyalgia - including pain, fatigue, morning stiffness, and depressed mood.’”

Vitamin D3

  • “It is an essential ingredient in reducing the symptoms of fibromyalgia.”

Stabilized R-Alpha Lioic Acid

  • “B vitamins and R-ALA are absolutely essential ingredients in helping to reduce the symptoms of fibromyalgia and ease nerve pain.”

Black Pepper Bioperine

  • “Bioperine…has immune-suppressing, tumor-inhibiting, and antidepressant effects.”

Your www.fibromyalgiatreatmentgroup.com/landers/1/ website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

  • “I tried your Fibrolief and I’m finally sleeping through the night. Doctors only gave me pain meds and sleep meds and I thought I was losing my mind. The pain throughout my body is mostly gone now, and my energy has returned.”
  • “I have been quite distressed with all the body pains and constant fatigue. After working my way through 5 doctors at a major hospital in Reno, I was diagnosed with fibromyalgia. Many of the medications did not help. Thankfully, I tried Fibrolief. This has been a major factor in dramatically decreasing the pain that I had. My energy has returned and I am again doing the things I love.”
  • “I have suffered with fibromyalgia for nearly four years. I was first diagnosed with chronic fatigue syndrome, but after the pain and other symptoms persisted, my doctor finally got the diagnosis right…The pain finally started to ease off after taking your product for about six weeks. I will continue using this as it is the first time in three years that I have felt so hopeful.”
  • “I was diagnosed with fibromyalgia in March of 2010. At that time I was suffering from severe pain and had no energy…I fell into depression which lasted a few years. My doctor prescribed me pain meds and anti-depressants, but they never really helped my condition…So I looked around on the internet and came across Fibrolief…I signed up for the 2 week trial…I did start to notice a difference in about 2 months…So I would definitely advise anyone with fibromyalgia to give Fibrolief a chance.”

Nerve Renew

Statements referring to Nerve Renew on www.neuropathytreatmentgroup.com:

  •  “Keep reading to learn how our breakthrough formula uses the latest research to repair damaged nerves”
  •  “That’s why I’d like to introduce you to a complete solution which doesn’t cut corners and packs the absolute purest forms of nutrients required to…Help control painful tingling and numbness in your feet so you can start enjoying a normal life again…Reduce throbbing pain signals by strengthening weak nerve cells so they can clearly communicate with out brain…Improve circulation in dying nerves by opening the tiny restricted blood vessels causing nerve pain…”
  •  “It helps your nerve pain (even if you’ve been suffering for years) by giving you the exact nutrients that unclog micro blood vessels, nourish weak nerve fibers, and help restore the function of your entire nervous system.”
  •  “As you can see, NerveRenew has transformed the lives of people all across the world. Not only has most of their pain, tingling and numbness went away, but their quality of life has improved drastically.”

Statements referring to Nerve Renew ingredients on
www.neuropathytreatmentgroup.com:

  • “Our powerful B6 also…Stabilizes erratic blood sugar…It acts as a natural painkiller, to helps [sic] reduce mild pain and discomfort…And strengthens your immune system by increasing the synthesis of antibodies, which protect your body from infection…”
  •  “The American Journal of Pharmacological Sciences says, ‘combining (B1, B6, and B12) produces a synergistic effect that, apart from participating in vital body functions, can help treat other health issues such as pain.”

Your www.neuropathytreatmentgroup.com website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

  •  “I've tried a lot of different over the counter pain products to help with the burning and tingling in my feet. I even just ‘Helicoptered’ Wes and Nerve Renew for about 2 months before I finally decided to give it a try. In about a week I saw results. It was a feeling of freedom that I hadn't felt in a long time. I could go places without discomfort!”

Additional testimonials were located at https://www.neuropathytreatmentgroup.com/te/E002/?utm_source=ntg_homepage&utm_campaign=learn_more recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

  •  “I have suffered with neuropathy for two years and my Neurologist had me on multiple medications which did little to relieve my pain and the extreme cold in my feet and legs. My husband found the Neuropathy Treatment Group on the web and ordered the formula. Within 7 days I could feel relief from the pain and a lessening of the coldness in my feet.”
  •  “When my trial shipment arrived, I took a Nerve Renew capsule and in just a few minutes, I noticed that the sharp pains in my feet started to diminish. I had been disabled by pain for several weeks and was not able to walk or function. By the next day, I started to walk again and I was able to function fairly normally…I rarely suffer from pain unless I forget to take Nerve Renew. Thank you for making Nerve Renew available.”

Neuro Boost Optimizer

Statements referring to Neuro Boost Optimizer on www.nerverenew.com:

  •  “Stress spells trouble for your pain…If your stress doesn’t go away your brain will continue to release more and more of these stress hormones - making your pain worse than it needs to be. Worse yet, it also causes other problems including:…Headaches, Increased blood sugar, High blood pressure, Insomnia. Neuro Boost Optimizer contains 3 proven ingredients to help your body cope with elevated stress hormones. . . . [E]ach of the 3 ingredients we use in Neuro Boost Optimizer can have a very beneficial impact on our neurological processes which translate to an improvement in migraines.”

Statements referring to Neuro Boost Optimizer ingredients on www.nerverenew.com:

  •  SAMe - 200 mg

“It works by improving mood while maintaining the brain chemicals serotonin, melatonin and dopamine in conjunction with modulating optimum levels of vitamin B-12. Studies have shown this ingredient to be more effective than
placebos in treating depression.”

Your www.nerverenew.com website contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

  •  “I was having nerve pain at night I started taking neuro boost optimizer and within 3 weeks the pain was gone...a great product.”

Immune Support

Statements referring to Immune Support ingredients on www.nerverenew.com:

  •  “The ingredients in this formula have been shown to help:…Reduce severity & duration of infections like the common cold or flu…Reduce the risk of chronic inflammation…”
  •  “And while each one is backed by numerous studies, there’s one that stands out above the rest. It’s called Beta-glucan…or, as researchers often refer to it: Nature’s Super Medicine…Beta-glucans are used clinically against diabetes, cancer, and high cholesterol, as well as to boost the immune systems of people whose immunity has been compromised by radiation, chemotherapy, stress, and other conditions.”
  •  “Here are just a handful of some of the many benefits identified in clinical studies of this powerful ingredient:…help fight chronic inflammation…Reversed immune system paralysis in patients whose immune systems had been compromised from sepsis.”

Your Fibrolief Support Formula, Nerve Renew, Neuro Boost Optimizer, and Immune Support products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d), § 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products Fibrolief Support Formula, Nerve Renew, Neuro Boost Optimizer, and Immune Support are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Fibrolief Support Formula, Nerve Renew, Neuro Boost Optimizer, and Immune Support fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].

Additionally, your website www.fibromyalgiatreatmentgroup.com/landers/1/ includes the statement, “Our manufacturing facility is FDA approved. . ..” FDA does not approve dietary supplement manufacturing facilities. Therefore, this statement is false or misleading. Even if your Fibrolief Support Formula were not an unapproved new and misbranded drug, it would be a misbranded food under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: CDR Joshua Wireman, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact CDR Joshua Wireman at 425-302-0345.

 

Sincerely,
/S/

Miriam R. Burbac
District Director
Program Division Director

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